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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Kit Multiplex (q)RT-PCR(X) for detection of SARS-CoV-2

Manufactured by DDS DIAGNOSTIC SRL, Romania - www.ddsdiagnostic.com 

Device identification number
2657
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Sputum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
- with lysis and extraction - with quantitative standards - direct amplification protocol
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Quantitative
Time
120 minutes
LOD
5 cpu
Positive control
Human RnaseP
Negative control
yes
Analytical Sensitivity
99 %
Analytical Specificity
100 %
Clinical Sensitivity
99 %
Clinical Specificity
100 %

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements